BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR 7.5 FR. 40CC IAB

    MDR report key: 7374754 · Received March 27, 2018

    Report

    Report Number
    2248146-2018-00204
    Event Type
    Death
    Date Received
    March 27, 2018
    Date of Event
    February 17, 2018
    Report Date
    June 14, 2018
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K041281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DECON OR VISUAL INSPECTION OF PRODUCT PERFORMED SINCE IT WAS NOT RETURNED. PICTURES WERE PROVIDED FOR THIS EVENT . A VISUAL REVIEW OF THE PICTURES HAS CONFIRMED THAT THERE WAS A SEPARATED INNER LUMEN IN ONE IAB AND THERE WAS BLOOD INSIDE OF ONE IAB, SO WE ARE CONFIRMING THE REPORTED EVENTS OF LEAK IN IAB AND DAMAGED INNER LUMEN FOR THESE CASES. THE PRODUCT WAS NOT RETURNED AND COULD ONLY BE EVALUATED PHOTOGRAPHICALLY. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. THE COMPLAINT WAS CONFIRMED BASED ON THE PICTURE PROVIDED WITH THE SEPARATED INNER LUMEN INSIDE THE IAB CATHETER, BUT WE ARE UNABLE TO EVALUATE THE PRODUCT TO DETERMINE A ROOT CAUSE. REFERENCE MFR REPORT # 2248146-2018-00203 FOR RELATED CASE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INSERTION OF TWO INTRA-AORTIC BALLOON (IAB) CATHETERS IN THE CARDIAC CENTER THAT THE FIRST ONE HAD ITS AXES BROKEN AFTER COMPLETION OF INSERTION PROCEDURE. THE IAB FILLED WITH BLOOD INTO THE BALLOON. IT WAS REPORTED THAT THE SECOND BALLOON EVENT HAD ITS AXES BROKEN DURING THE INSERTION DUE TO THE SHEATH WHICH WAS TOO TIGHT TO EASILY INSERT THE CATHETER INTO IT. FINALLY, A THIRD BALLOON CATHETER WAS INSERTED CORRECTLY. INDICATION FOR USE WAS DROP IN PRESSURE. THIS SUBMISSION IS FOR THE 2ND IAB USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INSERTION OF TWO INTRA-AORTIC BALLOON (IAB) CATHETERS IN THE CARDIAC CENTER THAT THE FIRST ONE HAD ITS AXES BROKEN AFTER COMPLETION OF INSERTION PROCEDURE. THE IAB FILLED WITH BLOOD INTO THE BALLOON. IT WAS REPORTED THAT THE SECOND BALLOON EVENT HAD ITS AXES BROKEN DURING THE INSERTION DUE TO THE SHEATH WHICH WAS TOO TIGHT TO EASILY INSERT THE CATHETER INTO IT. FINALLY, A THIRD BALLOON CATHETER WAS INSERTED CORRECTLY. INDICATION FOR USE WAS DROP IN PRESSURE. THIS SUBMISSION IS FOR THE 2ND IAB USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216100 LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD 3000058108

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death